3 million Ebola vaccines have been produced by Crucell, stockpiled since 2003

3 million Ebola vaccines have been produced by Crucell, stockpiled since 2003

10/26/2014
0832 am

The United States has had a vaccine for Ebola for nearly 11 years. The 3 million vaccines mass produced are a result of funding for Project Bioshield. 

The Ebola vaccines have been approved,tested in humans and ready to go but are being stockpiled in some military vault out of the publics reach.

CRUCELL labs has had the contract for many years to develop the vaccines. They delivered on their pact with the US Government to develop a vaccine. The vaccine is available.

The information below, nearly all of it, was pulled from the websites of CRUCELL and other governmental agencies.

To see this information so readily available and not reported simply amazes me. Then yet again, I am of the opinion that many things are left unsaid by our MSM, mainstream media,for a purpose.

Take a look at this information provided to you by CRUCELL the producer of the Ebola vaccines. This information is directly from the links provided. I have provided some text in parentheses.

In 2005, “Crucell is (has) developing an Ebola vaccine in collaboration with the Vaccine Research Center (VRC) of the NIH National Institute of Allergy and Infectious Diseases (NIAID). It has been shown to completely protect monkeys against the virus with a single dose of the vaccine.
Under the terms of the agreement with VRC, Crucell has an option for exclusive worldwide commercialization rights to the Ebola vaccine.”

“Crucell’s Ebola vaccine entered Phase I clinical trials in Q3 2006.  Two groups of 16 volunteers were enrolled and vaccinated. ”

“The study showed safety and immunogenicity at the doses evaluated.”

“In October 2008, Crucell secured a NIAID/NIH award to advance the development of Ebola and Marburg vaccines, with the ultimate aim of developing a multivalent filovirus vaccine.”

“The award provides funding of up to $30 million, with additional options, worth a further $40 million.”

“Development rationale:
To date, numerous attempts to PROTECT against Ebola infection using a variety of strategies have failed.”

“However, in 2003 a National Institutes of Health (NIH) study published in Nature demonstrated that a SINGLE DOSE of a recombinant vaccine provided solid protection against an otherwise deadly infection in animal models. Based on these results, we DECIDED TO DEVELOP an Ebola vaccine using the same approach.(For humans)”

“Furthermore, the Ebola virus is on the US government’s Category “A” list of bioterror agents.” 

“In 2003 the US government announced that, once available, an Ebola vaccine may be STOCKPILED as part of its preparation for bio-terror attacks under Project Bioshield.”

“The Bioshield Act was enacted in July 2004, with a total appropriation of US$ 5.6 billion across all programs.”

“Development status:
In 2002, we entered into a Collaborative Research and Development Agreement (CRADA) with the VRC of the NIH to develop jointly, test and manufacture an adenovirus-based Ebola vaccine. ”

“Under the terms of the agreement, we have an option for exclusive worldwide commercialization rights to the Ebola vaccine resulting from this collaboration.” 

“In August 2002, the CRADA was extended to cover vaccines against Marburg and Lassa infections. (Ebola-Z, Marburg and Lassa hemmorhagic fevers are the viruses responsible for destroying West Africa and now the US.)”

“In experiments conducted in 2004 by the VRC together with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), our vaccine candidate confirmed single-dose protection of monkeys against Ebola. Our results are distinct from the earlier trials in that our vaccine is based on PER.C6® cells, making it SUITABLE for large-scale manufacturing.”

“In 2005, we extended the CRADA with the VRC (Vaccine Research Center) of the NIH to develop and produce vaccines against Ebola, Marburg and Lassa infections.”

“Crucell was also granted an exclusive license to patents owned by the NIH to develop and commercialize vaccines against Ebola. ”

“Furthermore, Crucell signed a contract of up to €21.4 million (27 million US dollars)  with the NIH to produce Ebola vaccines. (In 2005, need I remind you)”

“Crucell’s Ebola vaccine entered Phase I studies in Q3 2006.” 

“For this randomized, double-blind, placebo-controlled study, two groups of 16 healthy volunteers were enrolled and vaccinated. The study showed safety SHOWED SAFETYand IMMUNOGENICITY at the doses evaluated.”

“Based on these results, a second Phase I study is anticipated (was done). This will use alternative multivalent adenovirus vectors that are able to bypass pre-existing immunity against the more commonly used adenovirus serotype 5 (Ad5).”

Look for your self at the link below! It’s evidently no big secret, just underreported!

http://www.crucell.com/R_AND_D_CLINICAL_DEVELOPMENT_EB.HTM

Click to access FACTSHEET_DEVELOPING_EBOLA___MA.PDF

Here is another offering of information about the development and production of an Ebola vaccine.

Crucell Lands EUR21M NIH (National Institute of Health) Contract To Produce Ebola Virus Vaccine (2005)

According to Cormac Sheridan, BioWorld International Correspondent: “Crucell NV gained what Chief Financial Officer Leonard Kruimer described as a larger-than-expected contract from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.”

“The contract is for manufacturing 10 clinical-grade batches of Ebola virus vaccine for use in Phase I and Phase II studies. The full value of the contract, which is set for about two and a half years, stands at €21.4 million (US$27.9 million)” (This amount backs up previous links)

“The vaccine is being developed (in 2005) under a Cooperative Research and Development Agreement between Crucell and the NIH, which also includes provisions for the development of vaccines against two other viruses that cause hemorrhagic infection, Marburg and Lassa.”

“The program is due to move into the clinic in the fourth quarter. Depending on the outcome of the initial studies, the NIH, of Bethesda, Md., might decide not to proceed with all 10 trials, Kruimer said.”

“Then you do not get all the revenues from this contract, but you have a product,” he said. The vaccine, which Crucell, of Leiden, the Netherlands, will produce using its PER.C6 human cell culture system, will not be eligible for full FDA approval but will be available under U.S. biopreparedness plans for administration to key personnel, including the military, government officials and health care workers, IN THE EVENT OF AN OUTBREAK!

“The government has indicated that they would be able to buy 3 million doses,” Kruimer said. “You’re talking about a market of $100 million, and that’s what we’re going for.”

“Additional human and animal studies would be required for full approval. A single dose of the recombinant vaccine, which is based on Crucell’s replication-deficient adenovirus vector expressing Ebola viral antigens, bestowed protection on macaque monkeys challenged with a lethal dose of Ebola virus in studies conducted last year by the Vaccine Research Center and the U.S. Army Medical Research Institute of Infectious Disease, located in Frederick, Md.”

“We are the only company in the world, which has developed a vaccine which keeps animals alive and disease-free after vaccination,” Kruimer said.

“Administrations in other countries also have expressed interest in the Ebola program, he said. IMPORTANT TO NOTE-“We will make sure it works in the United States and then we’ll take it from there.” (This was said in 2005)
http://www.bioworld.com/content/crucell-lands-eur21m-nih-contract-produce-ebola-virus-vaccine-0
Published: BioWorld Today, April 20, 2005

After years of research dating back to 2002, and making 3 million doses of the vaccine for the bio-terror program of the US Military, another Stage 1 trial is underway today, in 2014?  I don’t get it. Why are we initiating 2 trials 10 years apart to duplicate a product we already have and have stockpiled somewhere and could have easily produced enough in 10 years to offer us protection?
http://www.niaid.nih.gov/topics/ebolamarburg/research/pages/default.aspx

Fast forward to 2014-2015

Johnson and Johnson, who acquired CRUCELL recently says that the Ebola vaccine was tested on 8,300 patients and even added rabies vaccine tests. (Was this perhaps what locals were referring to when they said “they were giving them the virus?” Where did these 8300 come form and how are they now? And why are today doing vaccine research on 16 patients and why are we duplicating this process? )

The Ebola Vaccination trials going on as we speak for Ebola Zaire to develop a monovalent vaccine is underway with a trivalent Ebola, Marburg and Lassa vaccine on the horizon. Folks, we have already done this! We are doing it again? Why? Money?

We have a mono and a trivalent vaccine and had CRUCELL produce 3 million doses under Project Bioshield? Perhaps I’m missing something. Why are we going through 2 separate trials if our first one was wildly successful?

It would make sense to me that if we could mass produce 3 million Ebola vaccines bouncing around FDA approval via a fast track method couldn’t we also mass produce another batch of vaccines or produce more ZMAPP that has been shown to work at a fairly high efficacy?

Where are those 3 million vaccines being stored? At some US Military Bio lab? Perhaps in Fort Dietrich?

Russia recently asked for the vaccines successfully created in CRUCELLs initial vaccine production effort.

To date the Obama administration has refused Russia access to these vaccines. Russia is referring to the wildly successful 3 million vaccines produced under the guises of “Project Bioshield” and our 50.6 billion dollars.

http://www.whatdoesitmean.com/index1810.htm

The Project BioShield Act authorizes expedited procurement, streamlined personnel appointments, expedited peer review, biomedical countermeasures procurement, emergency use of medical countermeasures, and other biodefense activities.
http://www.astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Project-BioShield-Act-Fact-Sheet/

Project Bioshield, passed by the 108th US Congress, allocated 50 billion to fight potential bio terrorism. Bioshields funding was also to go forward to stockpile protective equipment, increased surveillance, detection of biological weapons and  to prepare State and Civilian hospital in the event the Ebola were to spread to American soil. I think we missed that target by a wide margin.

From my observations and recent experiences for some reason that 50 billion did not trickle down to US  hospitals badly in need of that stimulus money to protect nurses and healthcare workers.

I believe Congressional oversight  and other regulatory committees should be held accountable for this and other blunders regarding our nations response to this most recent US outbreak of Ebola.

This confirms our Bio Warfare efforts to not only produce a virulent and dangerous disease but to hold the treatment from a suffering public. 

Why have we said that the vaccines will not be ready till 2015? 

Why have 3 million vaccine shots hoarded in some military vault somewhere while thousands are dying and suffering? 

We had the funding, ie Project Bioshield and its 5.6 billion dollar infusion. Was this money wisely spent?

5.6 billion dollars could produce a whole lot of vaccines. At 3 million per hundred million we could have produced more than we needed for our entire populace and alot of Africa.

Obviously, this was not a priority.

http://en.m.wikipedia.org/wiki/Project_Bioshield_Act